Various preparations and biologically active additives representing protein hydrolyzates obtained from source material of animal origin, in particular, sea products such as Mytilidae mussels and fish, meat of mammals and the like are known from the prior art. Said protein hydrolyzates usually represent bioadditives intended for oral administration, either individually or in combination with other preparations, as well as a food additive.
DE 4309339 discloses biologically active pharmaceutical product of natural origin, which comprises acid hydrolyzate of molluscs belonging to genus Mytilus, comprising amino acids, melanoidins and trace elements of edible mussel (Mytilus edulis) and Mediterranean mussel (Mytilus galloprovincialis). In addition, the invention relates to various usages of the product. In particular, said product is used as a prophylactic, therapeutic radiopharmaceutical agent for humans and animals, has antipyretic properties and stimulates haemopoiesis, especially during radio- and chemotherapy.
Also known in the state of the art is the product MIGI-K (MIGI-K LP (M- ®), a liquid for oral administration, which represents a solution obtained by hydrolysis of Mediterranean mussels and used as a biologically active food supplement (see http://www.migiklp.ru).
Known in the art is a biologically active additive MIDEL (M) having general tonic effect, close in properties to MIGI-K obtainable from White Sea mussels meat. Therapeutic and remedial administration of MIDEL combined with conventional treatment methods or as an individual preparation is recommended in immune deficiency conditions of various etiologies.
One of the disadvantages of oral hydrolyzates obtained from Mytilidae mussels meat is a relatively low rate of the development of desired effect upon daily administration.
Immunomodulatory compositions obtained from source material of animal origin other than mussels are also known in the state of the art.
RU 2221456 discloses a universal biologically active substance (BAS), which is a protein hydrolyzate obtained by a method comprising acid hydrolysis followed by neutralization of fish meat and protein containing by-products of animal or fish origin; filtering to provide a hydrolyzate and a residue; and subsequently drying the hydrolyzate. The claimed BAS is disclosed to be used as a food additive for animals, as a base for veterinary preparation, oral alimentation, perfume and beauty products, dairy products, confectionaries, etc.
Additionally, various preparations and compositions based on hydrolyzates derived from fish meat are known from EP 1653981, US 2009111747, US 2011124570.
RU 2402320 discloses a preparation comprising various amino acids, salts and micronutrient elements in a form of aqueous solution, as well as a method for preventing and correcting pathological conditions in animals, consisting in injectable administration of said preparation to an animal organism for prophylactic purposes 2 times a week over a month in a dose of 1.5-2.0 ml per 10 kg body weight, for treatment purposes in a dose of 3.0-5.0 ml per 10 kg body weight 2 times per 24 hours over 3-5 days in case of intoxication with synthetic and/or food poisoning in a 10-fold therapeutical dose. In particular, subcutaneous or intramuscular administration of said preparation provides more efficient prophylaxis and treatment of diseases of various etiologies. However, the production of said synthetic preparation is a tedious and energy-demanding process which comprises developing optimal qualitative and quantitative compositions of aqueous solutions of amino acids, vitamins, micro- and macroelements and glucose, in order to normalize metabolic processes in an animal organism, and preparation techniques thereof.
Various injectable preparations, such as, for example, evinton, are also known in the state of the art. Due to a combination of three homeopathic ingredients, evinton stimulates phagocytic activity and promotes barrier function of lymph nodes, skin, and mucous membranes as well as of other organs and tissues. Evinton is an immunomodulator used for treating diseases of bacterial and viral etiology such as canine distemper, panleukopenia, parvoviral enteritis, viral hepatitis, rhinotracheitis, etc. Evinton is administered daily, a mode of treatment lasting from a few days (for viral enteritis) up to 2-3 weeks (for viral hepatitis).
All the above-identified compositions have relatively low therapeutic and preventive efficiency. Beneficial effect upon oral administration of the preparations obtained from aquatic bioresources usually develops after a long period of time, provided that they are used in continuous manner. Oral preparations are used as biologically active food supplements, where the amount of preparation consumed over the entire course varies significantly and can be from tens of millilitres to a few litres. Moreover, the known injectable preparations do not possess broad spectrum of effects, probably due to their not sufficiently balanced composition, as in the case of, e.g., synthetically produced compositions, or, depending on their natural origin, as in the case of fish hydrolyzates, failing to comprise a full set of ingredients necessary and sufficient for achieving rapid preventive or therapeutic effect in human and animals.
Therefore, the present disclosure provides a composition having various therapeutic and preventive properties allowing one to achieve the desired positive effect within relatively short period of time regardless of a patient's ability and/or willingness to take food, ability and possibility of swallowing the composition and/or difficulties associated with its gastrointestinal uptake. Such composition may turn out to be particularly useful in veterinary medicine, where in many cases an animal suffering from a pathological condition or being in need of prophylactic agents for a certain disease, refuses to take food comprising oral preparation due to unpleasant taste and/or odour of the latter. The present composition solves this problem as well.
It was surprisingly found that properties of the composition disclosed herein include immunomodulatory activity, phagocytic activity, hepatoprotective activity, adaptogenic activity, antiherpetic activity, detoxifying activity, antiviral activity, and antibacterial activity, burn treating and wound healing properties. Moreover, said therapeutic effect can be achieved after the first few applications of the composition. In some cases therapeutic improvement is observable since the very first application of the present parenteral composition.
The present disclosure further provides a method for preparing the above-identified composition. Said method is simple in technique and its implementation does not require special manufacturing facilities and high professional skills, thereby contributing to its higher economic efficiency.
The composition for the parenteral administration is used in treating and/or preventing a pathological condition in a mammal in need thereof. That is to say, in other aspect the present disclosure provides a method of treating and/or preventing a pathological condition of various etiology in a subject in need thereof, the method comprising administering the above-identified composition. Said method includes an optimal dosage schedule for administering the composition, providing beneficial preventive and/or therapeutic effect while exhibiting no adverse effects irrespective of a subject's individual parametres; in particular not a single case of individual intolerance to the composition was observed in a mammal throughout clinical trial period.
Thus, the present disclosure provides an composition for parenteral administration, the composition comprising a hydrolyzate obtained from biological material of animal origin, methods for preparing said composition, the methods of treating and/or preventing a pathological condition in a mammal in need thereof using the composition described herein, and various other uses of said composition for medical and veterinary purposes.